Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency

University of Virginia37 enrolled

Overview

This study is trying to find out if an undetectable serum immunoglobulin E (IgE) is a biomarker, or early sign of, the development of immune deficiency.

IgE is the antibody thought to be responsible for developing allergies. Undetectable serum IgE (an IgE below the lower limit of detection) is found in about 3% of the general population. In the past, it has been thought that having an undetectable IgE does not have any health impact, other than meaning that you are at low risk for having allergies. However, recent studies of patients with undetectable IgE have shown higher rates of infections, autoimmune disease and cancer. Patients with an immune deficiency called common variable immunodeficiency (CVID) also have higher rates of infections, autoimmune disease and cancer. Recently, we have shown that most patients with CVID have a low/undetectable serum IgE. This study is trying to find out if an undetectable serum IgE is a biomarker, or early sign of, the development of CVID or other antibody deficiencies

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Immune Deficiency

Interventions

Salmonella typhi polysaccharide vaccineBIOLOGICAL

Salmonella typhi polysaccharide vaccine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-80 * Willingness and ability to comply with scheduled visits and study procedures * Undetectable serum IgE (defined as \>2 IU/mL or the lower threshold of detection) * Normal or high serum immunoglobulins (within or above laboratory reference range for IgG, IgA, and IgM) * patients previously seen at the University of Virginia Asthma, Allergy, and Immunology clinics where undetectable serum IgE was noted * Control subjects must have participated in study IRB#14457 (only applicable for healthy controls in epsilon germline transcript portion of the study) Exclusion Criteria: * The following vulnerable populations will be excluded: pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, educational or economically disadvantaged, non-English speaking subjects * Known personal history of immunodeficiency * Known personal history of recurrent infections * Low serum immunoglobulins (below the laboratory reference range for IgG, IgA, or IgM) * Recent or current treatment with systemic immunosuppression within the past 30 days

Locations (1)

University of Virginia Health System

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

Vaccination response

IgG to Salmonella typhi will be measured, with a normal response calculated as at least a 2-fold increase in IgG titers post-vaccination

Time frame: 4-6 weeks

Secondary Outcomes

Epsilon germline transcript production

B cells isolated from subjects will be evaluated to determine their ability to produce Epsilon germline transcript in response to stimulation

Time frame: 3 days

Data from ClinicalTrials.gov

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